deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT01126216

Reduced Radiotherapy With Pac/Cis vs Standard Radiotherapy With 5-FU/Cis in Locally Advanced Head and Neck Cancer (Paccis-RCT)

Randomised Phase-III-trial of Simultaneous Radiochemotherapy (RCT) of Locally Advanced Head and Neck Cancer in the Stages III and IV A-B: Comparing Dose Reduced Radiotherapy (63,6 Gy) With Paclitaxel/Cisplatin to Standard Radiotherapy (70,2 Gy) With 5-Fluorouracil/Cisplatin

Sponsor: Deutsche Krebshilfe e.V., Bonn (Germany)

Updated 8 times since 2017 Last updated: Apr 28, 2021 Started: Jun 30, 2010 Primary completion: Jun 30, 2015 Completion: Jun 30, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

After an Interims analysis the Data Safety Monitoring board recommended this because no significant difference between the two arms was seen and was not expected with an reasonable recruitment of patients.~No interruptions of the trial were made.

A PHASE3 clinical study on Head and Neck Cancer, this trial is terminated or withdrawn. The trial is conducted by Deutsche Krebshilfe e.V., Bonn (Germany) and has accumulated 8 data snapshots since 2010. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Sep 2019 · 15 months · monthly snapshotActive Not Recruiting~Sep 2019 – ~Jan 2021 · 16 months · monthly snapshotUnknown Status~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshotUnknown Status~Jun 2021 – ~Dec 2021 · 6 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 24 months · monthly snapshotTerminated

Change History

8 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  4. Jun 2021 — Dec 2021 [monthly]

    Terminated PHASE3

    Status: Unknown StatusTerminated

  5. Jan 2021 — Jun 2021 [monthly]

    Unknown Status PHASE3

Show 3 earlier versions
  1. Sep 2019 — Jan 2021 [monthly]

    Unknown Status PHASE3

    Status: Active Not RecruitingUnknown Status

  2. Jun 2018 — Sep 2019 [monthly]

    Active Not Recruiting PHASE3

  3. Jan 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Jun 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Deutsche Krebshilfe e.V., Bonn (Germany)
  • University of Erlangen-Nürnberg Medical School
Data source: University of Erlangen-Nürnberg Medical School

For direct contact, visit the study record on ClinicalTrials.gov .